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̽»¨ºÏ¼¯ is seeking an experienced Associate Director for a role in overseeing Quality Control Stability. The successful candidate will be responsible for setting up and overseeing a compliant stability program. This role involves leading stability studies, driving continuous improvement and supporting compliant testing applications for marketing approval and commercial supply.

Responsibilities:

• Lead and oversee the QC Stability team.
• Manage the compliant stability program, including sample management, stability studies, and trending activities.
• Write and review SOPs, summary, and trend reports.
• Establish and maintain procedures for a compliant stability program.
• Manage stability chambers setup and equipment validation.
• Lead complex investigations into OOS or OOT results with cross-functional experts.
• Troubleshoot assays and implement solutions to drive continuous improvement.
• Oversee external vendors/contract testing facilities for QC Stability testing needs.
• Create and support execution of stability programs for products.
• Review and complete documentation in accordance with cGMP.
• Handle change control and deviations related to QC Stability.
• Author QC regulatory documentation and assist in regulatory audits/inspections.
• Develop and maintain a culture of continuous improvement within the QC team.
• Plan capacity for the QC Stability group to ensure resource availability.
• Oversee the QC Stability team, including performance management and personnel development.

Key Skills and Requirements:

• Degree in Chemistry, Biochemistry, Microbiology, or related science.
• Experience in GLP/GMP environments and laboratory-based testing.
• Management experience in a GMP-regulated environment.
• Strong analytical skills and technical experience in product/raw materials testing.
• Knowledge of statistical packages such as JMP.
• Proficiency in MS Word and Excel.
• Effective communication and organizational skills.
• Ability to work well as a team.

If you are having difficulty in applying or if you have any questions, please contact Ingrid Aymes at i.aymes@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

̽»¨ºÏ¼¯ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ̽»¨ºÏ¼¯ is acting as an Employment Agency in relation to this vacancy.